Data Science Policy Specialist in Regulatory Affairs

2 weeks ago

Søborg, Denmark Novo Nordisk AS Full time

Do you want to work with policies and regulation on advanced data science capabilities and methodologies ? Do you enjoy working in a fast-changing environment where engaged people have a unique combination of scientific and technical insight and ability to navigate political agendas and external stakeholders? If yes, you might be the new Data Science Policy Specialist we are looking for in Regulatory Affairs.

We are seeking an enthusiastic specialist to be at the forefront of bridging the gap between advances in data science and the evolving regulatory and policy landscape. As a Data Science Policy Specialist, you will support external engagements that advance innovative data science methodologies and ensure alignment with global regulations, guidance, and policy. Utilizing your expertise, you will advocate for the acceptance and alignment of innovative data science methodologies with global regulations and guidelines. Your contributions will be instrumental within prioritized data science areas including real world evidence (RWE), artificial intelligence (AI), machine learning, digital health technologies (DHT), decentralized trials and other opportunities that are transforming the regulatory landscape. Your strategic insights will support co-developed initiatives and policy strategies that shape the future of healthcare regulation.

About the Department


You will join the Regulatory Affairs (RA) Policy & Intelligence department as our new Data Science Policy Specialist. Overall, our role is to ensure compliance with new regulatory requirements and to influence the external regulatory environment to support Novo Nordisk’s product development and life-cycle management strategies.

We are a senior team that works closely with the various product- and project teams in Global Regulatory Affairs to support their work from a policy and intelligence perspective. As our Data Science Policy Specialist, you will work closely with the product development teams in Global regulatory Affairs as well as with the Novo Nordisk Data Science EVP-area to identify and address external key barriers and opportunities that can be leveraged via policy and advocacy activities. You will also work closely with a wide range of other Novo Nordisk departments, such as Digital Health IT, Device R&D, Commercial, and Medical & Science.

We embrace remote working and the hybrid workplace. We are a team with members based in Søborg - Denmark, Istanbul - Turkey, Bangalore - India, Tianjin - China, and Washington DC - US.


The Position


The role includes:

Landscape Analysis and Prioritisation: Communicate new regulatory requirements, guidelines, and trends within pre-agreed priority focus areas to relevant product/development project teams, regions, and management teams. Provide guidance to cross-functional teams on regulatory requirements and implications related to data science initiatives, fostering a culture of collaboration and knowledge sharing. Anticipate internal and external business challenges and issues and recommend and implement process updates and external strategies to address them. Strategic Policy Planning: Collaborate with internal and external stakeholders to device and execute strategies to engage with the external eco-system on data science and healthcare regulation. External engagement: Support interactions to explore and advance innovative data science methodologies, ensuring alignment and acceptance with global regulations and guidelines. Present at, or support other NN presenters at external workshops, conferences, and meetings, including those with regulators and academia. Act as one of Novo Nordisk’s key representatives on Data Science Policy-related issues in external fora.

You will report to the Head of RA Policy & Intelligence.

Qualifications

MSc and/or Ph.D in a relevant field such as Data Science, Pharmaceutical Sciences, or similar A minimum of 5 years of experience in regulatory affairs, regulatory science, health policy, or a related field, with a strong understanding of data science methodologies and their application within the healthcare industry. A deep understanding of the evolving regulatory landscape and the needs of agencies in relevant areas such as real world evidence (RWE), artificial intelligence (AI), machine learning, Quantitative Medicine, Digital Twins, Digital Therapeutics, and others. Experience from working with or in industry associations. Ability to communicate complex topics scientifically and professionally Stakeholder management competencies and a bility to support strong collaboration across our Global Regulatory Affairs and Data Science Fluency in written and spoken English is a non-negotiable requirement

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